Impact of neurochecks on cognitive outcomes in older patients with brain injury
Short-term And Longer-term Cognitive Impact Of Hourly Neurochecks In Acute Brain Injury
This study is testing if changing how often older patients with brain injuries get neurological checks in the ICU can help them think better and reduce confusion.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT06219889 on ClinicalTrials.gov |
What this trial studies
This research investigates how the frequency of neurological examinations, known as neurochecks, affects cognitive outcomes and delirium in older patients with acute intracerebral hemorrhage. Patients will be randomized to receive either hourly or every-other-hour neurochecks in the NeuroICU, where specialized teams provide care. The study aims to determine if adjusting the frequency of these checks can mitigate the risk of delirium and improve long-term cognitive health. Data will be collected on patient demographics, sleep quality, and clinical outcomes throughout their ICU stay.
Who should consider this trial
Good fit: Ideal candidates are older adults over 55 years with spontaneous acute intracerebral hemorrhage between 10cc and 40cc in volume.
Not a fit: Patients with unstable intracranial bleeding, pre-existing cognitive impairments, or severe sedation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cognitive outcomes and reduced delirium in older patients recovering from brain injuries.
How similar studies have performed: While the approach of modifying neurocheck frequency is innovative, similar studies have shown that managing delirium in ICU settings can lead to improved patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria (Part 1): 1. Adult patients (age \>18 years) with spontaneous acute \<45cc in volume with radiographic and clinical stability for ≥6 hours following admission to the ICU. These criteria are based on the literature and experience of the investigative team. 2. Additional intraventricular hemorrhage (with or without external ventricular drain) is allowable. 3. Only first admission to the NeuroICU during the hospitalization will be eligible. Inclusion criteria (Part 2): a. any patient included in part 1 alive at 6 months post-discharge Exclusion Criteria: 1. Patients with unstable intracranial bleeding 2. Patients with known history of intracranial neurological injury 3. Pre-existing cognitive impairment (known or highly suspected based on family-provided history, Activities of Daily Living Questionnaire) 4. Pre-existing diagnosed sleep disorder 5. Comatose or heavily sedated 6. Death expected within 30 days or other terminal illness 7. ICH score \>4 (equivalent to mortality risk \>72%) 8. Pregnancy 9. Incarcerated 10. Non-English or non-Spanish speaking
Where this trial is running
San Diego, California
- UC San Diego Health — San Diego, California, United States (Recruiting)
Study contacts
- Study coordinator: Jamie N LaBuzetta
- Email: jlabuzetta@ucsd.edu
- Phone: 18582491331
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.